Diabetes Clinical Trial
Official title:
OPtimized Stenting Using IVUS in Long lEsion: Rationale for Simplified criteriA
Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been
specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization
(AVIO) study was performed with (medical device's type )Promus stent, results are promising,
but the study was not designed for clinical endpoint.
There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely
used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were
recently proposed for complex lesions, but these criteria also have some issues and the
complexity make their routine use challenging.
We performed a pilot study for long complex lesion analysis using IVUS, in order to define
easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The
new criteria (OPERA) are an adaptation of the MUSIC criteria.
OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major
Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the
study.
Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element
stent deployment?
Study design This study will consist to prospectively include consecutive patients with>28mm
taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to
reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients
from the OTELLO study, with the same inclusion criteria, will composed the control group .
Population will be matched using the propensity score.
20 to 30 French centers involved in OTELLO study will be contacted for participating in
OPERA.
Hypothesis:
Long lesion percutaneous coronary intervention(PCI) have specific characteristics like
Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter
Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the
balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA
criteria have better outcomes than without IVUS
Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial
infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm
implantation
Secondary endpoint
1. MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria
2. Safety: procedural Stroke, Urgent cardiac surgery, procedural MI
3. Comparison of IVUS criteria: OPERA, MUSIC, AVIO
Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non
expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm
implantation with IVUS and OPERA criteria
Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric
study propensity score matched analysis matched for comparison to OTELLO study. (Same
inclusion criteria as OTELLO)
Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in
the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number
of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions.
Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts
Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months
telephone contact
Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization
(TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery,
According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05594446 -
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
|
||
Completed |
NCT03975309 -
DHS MIND Metabolomics
|
||
Completed |
NCT01855399 -
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
|
N/A | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05007990 -
Caregiving Networks Across Disease Context and the Life Course
|
||
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT04903496 -
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
|
||
Completed |
NCT01437592 -
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT03390179 -
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Recruiting |
NCT05294822 -
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
|
N/A | |
Completed |
NCT04427982 -
Dance and Diabetes/Prediabetes Self-Management
|
N/A | |
Completed |
NCT02356848 -
STEP UP to Avert Amputation in Diabetes
|
N/A | |
Completed |
NCT03292185 -
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
|
Phase 1 | |
Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 |